Clinical Research Study Start-up Documents |
Clinical Terms of Award |
| NIDCR Clinical Terms of Award |
The NIDCR policy that applies to grants involving human subject research. |
Protocol Templates |
| NIDCR Intervention Protocol Template |
Required for developing an NIDCR-funded clinical research protocol that utilizes an intervention (a drug, device, therapy or process under investigation). The template provides instructions (in italicized font); suggested text (in regular font) that can be included in your protocol. |
| NIDCR Intervention Protocol Working Shell |
Contains headers and formatting for use in writing your protocol. Refer to the Interventional Protocol Template for instructions and suggested text. As appropriate, modify the suggested text for your specific protocol. |
| Minimal Risk Protocol Template |
Describes the elements required for a simple minimal risk research protocol. |
Summary of Changes for Protocol Amendments Template
(Word - 47KB) |
Used to list changes made from a previous version of a protocol or consent document; informs the IRB and other readers of the changes between final versions. |
Protocol Associated Documents |
Informed Consent Checklist
(Word - 28KB) |
Lists essential and additional elements required by the Office of Human Subject Protections; should be used to review the content of the informed consent form. |
| Version Control Guidelines |
Provides instruction on how to number draft and final documents. Version control should be used for clinical research documents, including the protocol, consent document, case report forms, and Manual of Procedures. |
Manual of Procedures (MOP) Template
(Word - 280KB) |
Provides instructions for consistent study procedure implementation and data collection across participants and clinical sites. Details the study’s organization, operations, study procedures, data management, and quality control. |
Standard Operating Procedure (SOP)
(Word - 35KB) |
Used to develop a Standard Operating Procedure (SOP). Provides standard formatting and sample section headings that can be customized. |
Data and Safety Monitoring |
| NIDCR Policy on Data and Safety Monitoring |
Policy for establishing system of appropriate oversight and monitoring of the conduct of NIDCR-supported clinical research. Describes the format of oversight for different types of clinical research, including observational, specimen collection, biomedical, and behavioral intervention studies. |
| Data and Safety Monitoring Board (DSMB) Guidelines |
Describes the roles and responsibilities of the DSMB, including its organization, meeting format, and reports. |
DSMB Charter Template
(Word - 150KB) |
Used for clinical trials that include medical and non-medical interventions. Describes the composition, responsibilities, and communication of the committee. |
DSMB Report Template
(Word - 340KB) |
Provides a recommended structure for reporting data to the DSMB. Includes example text, instructions, and sample data tables. |
NIDCR DSMB Conflict of Interest Template
(Word - 42KB) |
To be completed by invited, prospective DSMB members; used to identify any conflicts of interest in studies that will be reviewed by the DSMB. |
| Clinical Study Oversight Committee (CSOC) Guidelines |
Describes the roles and responsibilities of the CSOC, its membership and reports, and types of studies requiring a CSOC. |
CSOC Charter Template
(Word - 127KB) |
Used for clinical studies not involving an intervention. Such studies may be complex, involve risk or vulnerable populations, and may be observational, specimen collection, epidemiology, or surveillance studies. Describes the composition, responsibilities and communication of the committee. |
CSOC Report Template
(Word - 523KB) |
Provides a recommended structure for reporting data to the CSOC. Includes example text, instructions, and sample data tables. |
CSOC Conflict of Interest Template
(Word - 43KB) |
To be completed by invited, prospective CSOC members; used to identify any conflicts of interest in studies that will be reviewed by the CSOC. |
| Safety Monitoring Committee Guidelines |
Describes the membership and roles of the SMC for the oversight of Phase I and smaller Phase II trials. |
| Independent Safety Monitor (ISM) Guidelines |
Describes the role of the ISM in monitoring the safety of a study. |
Essential Documents/Regulatory Binder |
Extramural Essential Documents Binder Tabs (Instructions)
(Word - 2.9MB)
Extramural Essential Documents Binder Tabs
(Word - 2.9MB) |
Provides instructions for organizing essential documents for clinical research in an Essential Documents Binder. Sometimes called an Investigator Binder or Regulatory Binder, this is retained at the investigator’s clinical site or office. Samples of documents to be filed in the Investigator Binder are included.
Used to print tabs for the Essential Documents Binder (sometimes called the Investigator Binder or Regulatory Binder), which is retained at the investigator's clinical site or office. Samples of documents to be filed in the Binder are below. |
NIDCR Investigator Record Agreement
(Word - 35KB) |
To be completed by NIDCR investigators; states that the investigator agrees to comply with the protocol and Good Clinical Practices. Once completed, contains key information including the location of the clinical research and IRB. |
Financial Disclosure Form
(Word - 41KB) |
Required for any clinical study submitted to FDA under an IND or IDE. Allows clinical research staff to disclose financial interests in a product under investigation. |
Steps for Completing the Financial Disclosure Form
(Word - 29KB) |
Instructions for completing the Financial Disclosure Form for investigators participating in an FDA regulated study. |
Regulatory Document History Log
(Word - 53KB) |
Used to organize date and topic of correspondence between the investigator and FDA. |
Delegation of Responsibilities
(Word - 34KB) |
Used to list all study personnel and their specific responsibilities, signatures, and dates of obligation during the conduct of a clinical research study. |
Training Log
(Word - 35KB) |
Documents study-specific training completed by staff exhibiting their qualifications to perform tasks involved in the clinical research study. Other training may also be listed on this log. |
Site Screening and Enrollment Log
(Word - 50KB) |
Used to list subjects screened; includes those who fail screening and those who are enrolled. |
Investigational Product Accountability Log: Stock Record
(Word - 82KB)
Investigational Product Accountability Log: Subject Record
(Word - 86KB) |
Used to document all study product disposition and accountability on the site level.
To be completed by NIDCR investigators for studies using investigational product; provides a comprehensive list of product disposition on a subject/participant level. Assists in compliance with the protocol and Good Clinical Practice. |
Specimen Tracking Log
(Word - 56KB) |
Used to track the type of clinical specimen, purpose of storage, and location of storage. Also helpful to identify if the subject consented for the sample to be retained for future research. |
Monitoring Visit Log
(Word - 36KB) |
Completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits. |
Subject Code List
(Word - 51KB) |
Used to document the subject/participant study identification number, name, and other identifying information. Must be stored securely and separate from research records since it is the link between a study ID and subject’s name. |
Telephone Contact Form
(Word - 46KB) |
Used to document pertinent study-related telephone conversations with regulating bodies (FDA, IRB) NIDCR, and others. Not intended to document conversations with study subjects/participants. |
Telephone Log
(Word - 54KB) |
Used to document study-specific conversations with a study subject/participant. |
IND Applicability Checklist
(Word - 59KB) |
Used by an investigator to help determine if the study must be submitted to FDA for an Investigational New Drug Application (IND). |
Data Management |
Data Management Considerations
(Word - 68KB) |
Helps an investigator evaluate the data management system’s ability to capture and validate data that is collected on paper or electronically. |
Clinical Data Management Plan Template
(Word - 1.41MB) |
Provides a customizable template for studies using an Electronic Data Capture (EDC) system. Sections may be edited or deleted as needed. |
Enrollment Report Template
(Excel - 50KB) |
May be used to report study subject accrual and completion numbers to OCTOM. Includes definitions of study status and recruitment status terms. |
Memo of Odd Data and Errata (MODE)
(PDF - 27KB) |
Used to document data oddities and how they will be handled during statistical analysis. |
Protocol Deviation Tracking Log
(Word - 47.4KB) |
Used to record all protocol deviations that occur at a study site. |
Pharmacy/Investigational Product |
Pharmacy Guidelines for Clinical Trials
(PDF - 109KB) |
Offers investigators guidance on handling study products and complying with state and federal regulations and institutional policies and procedures. The Guide should be reviewed for clinical trials using marketed or investigational bio-medical products. |
Study Product Guidelines and Considerations
(Word - 74KB) |
Provides considerations and best practices for receipt, storage, use, and disposition of study products used in a clinical trial. Should be reviewed for clinical trials using marketed or investigational bio-medical products. |
Clinical Site and Study Start-up |
Extramural Site Activation Checklist
(Word - 72KB) |
Provides a list of items required prior to site activation and tracks completion of tasks. |
Site Assessment Questionnaire
(Word - 204KB) |
Completed in collaboration with the clinical site monitor, investigator, and clinical site staff. Used to assess the staff experience with clinical research studies, facilities, and other operational needs to perform a clinical research study. |
Site Initiation Visit Agenda Template
(Word - 58KB) |
Describes topics, tasks, and operations that are discussed during a site initiation meeting to ensure all staff, facilities, and procedures are in place to conduct the clinical research study. |
Task Distribution List
(Word - 333KB) |
Identifies who on the clinical research team is responsible for completing or managing specific tasks. |
Educational Materials |
Clinical Care vs. Research Slides
(PPT - 1.41MB) |
Clarifies similarities and differences between clinical care and clinical research. |
Clinical Monitoring Overview
(PPT - 50KB) |
Reviews the site clinical monitoring process, types of visits, and monitoring activities that are completed during and following these visits. |
Good Clinical Practice (GCP) Overview
(PPT - 27KB) |
Provides an overview of Good Clinical Practice standards and reviews the PI's commitments under GCP. |
Good Documentation Practice (GDP) Overview Slides
(PPT - 47.4KB) |
Provides an overview of Good Documentation Practice standards and practices. |
Clinical Research Responsibilities Slides
(PPT - 171KB) |
Provide an introductory overview of the roles and responsibilities of an investigator conducting NIDCR clinical research. Reviews human subject protection, research planning, protocol adherence, and documentation. |
Quality Management |
An Introduction to Site-Level Quality Management within the Clinical Research Process
(PPT - 1.41MB) |
Clarifies Quality Management as it relates to site-level documentation, processes, and activities. Reviews tools available to support site-level QM. |
Clinical Quality Management Plan (CQMP) Template
(Word - 50KB) |
Used as a starting point for preparing a CQMP. Provides a proposed structure, sample language, and other guidance. |
Quality Management of Clinical Research – Brief Overview
(Word - 27KB) |
Reviews QM term definitions and activity examples, and provides an overview of available tools and templates. |
Quality Management Study-wide Review Tool
(Word - 47.4KB) |
Provides structure for QM review of study-wide materials and processes. Sample text is included that should be customized for study-specific needs. |
Quality Management Subject/Participant Data Review Tool
(Word - 48.4KB) |
Provides structure for QM review of subject data and associated materials. Both single subject and multiple subject formats are provided. Sample text is included that should be customized for study-specific needs. |
Quality Management Summary Report Template
(Word - 49.2KB) |
Summarizes the results of site-level QM efforts and provides a framework for reporting results of QM activities. |
Documents to be Used During the Conduct of Clinical Research |
Unanticipated Problems (UP) Form
(Word - 78KB) |
May be used to document and report unanticipated problems to the study sponsor (NIDCR) and the IRB. |
Serious Adverse Events (SAE)
(PDF - 222KB) |
For reporting NIDCR Serious Adverse Events (SAEs) to NIDCR’s Clinical Research Operations and Management Support (CROMS) contract. |
Notes to File template
(Word - 53 KB) |
Used by clinical site staff to document a discrepancy or problem with the conduct of the clinical research study, and plans to resolve and prevent the problem from recurring. May be used to document a Corrective and Preventive Action Plan (CAPA). |
Documenting the Consent Process
(Word - 43 KB) |
Provides a framework for documenting the consent discussion and process with a potential study subject. May be modified to suit the needs of the clinical research study. |
Clinical Research Study Completion & Close-out Documents |
Study Close-out Checklist
(Word - 68KB) |
Helps the investigator plan orderly closure of study documents, data, and publication. |